Previous Job
Previous
Clinical Specialist I
Ref No.: 18-09830
Location: Marlborough, Massachusetts
Clinical Specialist I
Marlborough, MA
1 Year

POSITION TITLE - CLINICAL SUPPORT ASSOCIATE



This is an entry level position and the candidate will spend a lot of time scanning and filing documents. We don't need anyone with an advanced degree. We need someone who is well organized and has high attention to detail as they will be doing document reconciliation as well. The ideal candidate will also be reliable, able to work both independently and systematically on multiple tasks as well as part of a team.

Key responsibilities/essential functions include (but are not limited to):

1. Assist the GxP Operation team with the inspection readiness of TMF/eTMF records for clinical studies; work with internal staff as necessary for document reconciliation
2. Assist the archivist with tracking and transfer of paper records to off-site archives for permanent storage
3. Assist with retrieval and return of legacy Clinical Trials documentation at offsite storage facilities
4. Assist with management of TMF regulatory documents associated with clinical supplies. Work closely with Client Clinical Support Analyst and vendor to assure filing of documents into TMF/eTMF.
5. Perform scanning of clinical trial and training documentation for electronic filing and storage.






Desired Characteristics:

1. Prior knowledge of the clinical trials process and Good Clinical Practices.
2. Well organized and structured, attention to detail.
3. Able to work independently and systematically on multiple tasks.
4. Diplomatic, cooperative team worker.
5. Ability to prioritize assignments and deliver according to defined milestones & multiple projects.
6. Able to work well independently as well as function as a cohesive member of a team.
7. Proficient with Microsoft Word and Excel.
8. Strong attention to detail and understands importance of timelines; strives to adhere to and meet deadlines.